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CTRI Number  CTRI/2025/12/098750 [Registered on: 10/12/2025] Trial Registered Prospectively
Last Modified On: 10/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Hysteroscopy procedure without cervical preparation 
Scientific Title of Study   Evaluating The Efficacy And Safety Of Hysteroscopic Procedures Without Cervical Priming Compared To Misoprostol Cervical Priming In Premenopausal Women: An Equivalent Randomized Controlled Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Yogita Satpute 
Designation  PDCC - gynaecological endoscopy 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  AIIMS Nagpur
MIHAN Khapri
Nagpur
MAHARASHTRA
441108
India 
Phone  7768952185  
Fax    
Email  satputeyogita23@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amruta Choudhary 
Designation  Assistant Professor, Obstetrics ang Gynaecology 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  AIIMS Nagpur
MIHAN Khapri
Nagpur
MAHARASHTRA
441108
India 
Phone  8600031166  
Fax    
Email  dramruta85@aiimsnagpur.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Yogita Satpute 
Designation  PDCC - gynaecological endoscopy 
Affiliation  All India Institute of Medical Sciences, Nagpur 
Address  AIIMS Nagpur
MIHAN Khapri
Nagpur
MAHARASHTRA
441108
India 
Phone  7768952185  
Fax    
Email  satputeyogita23@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical Sciences, Nagpur 
 
Primary Sponsor  
Name  self 
Address  AIIMS Nagpur, plot no. 2, sector 20, MIHAN Khapri, Nagpur PIN - 441108 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Yogita Satpute  All India Institute of medical sciences, Nagpur  Department of obstetrics and gynaecology, IPD building, AIIMS Nagpur Plot no. 2 , sector 20, MIHAN, Nagpur - 441108
Nagpur
MAHARASHTRA 		 7768952185

satputeyogita23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N719||Inflammatory disease of uterus, unspecified, (2) ICD-10 Condition: N72||Inflammatory disease of cervix uteri, (3) ICD-10 Condition: N840||Polyp of corpus uteri, (4) ICD-10 Condition: N841||Polyp of cervix uteri, (5) ICD-10 Condition: N850||Endometrial hyperplasia, (6) ICD-10 Condition: N856||Intrauterine synechiae, (7) ICD-10 Condition: N857||Hematometra, (8) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, (9) ICD-10 Condition: N859||Noninflammatory disorder of uterus, unspecified, (10) ICD-10 Condition: N910||Primary amenorrhea, (11) ICD-10 Condition: N911||Secondary amenorrhea, (12) ICD-10 Condition: N912||Amenorrhea, unspecified, (13) ICD-10 Condition: N913||Primary oligomenorrhea, (14) ICD-10 Condition: N912||Amenorrhea, unspecified, (15) ICD-10 Condition: N914||Secondary oligomenorrhea, (16) ICD-10 Condition: N915||Oligomenorrhea, unspecified, (17) ICD-10 Condition: N920||Excessive and frequent menstruation with regular cycle, (18) ICD-10 Condition: N921||Excessive and frequent menstruation with irregular cycle, (19) ICD-10 Condition: N923||Ovulation bleeding, (20) ICD-10 Condition: N924||Excessive bleeding in the premenopausal period, (21) ICD-10 Condition: N924||Excessive bleeding in the premenopausal period, (22) ICD-10 Condition: N925||Other specified irregular menstruation, (23) ICD-10 Condition: N926||Irregular menstruation, unspecified, (24) ICD-10 Condition: N938||Other specified abnormal uterine and vaginal bleeding, (25) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, (26) ICD-10 Condition: N948||Other specified conditions associated with female genital organs and menstrual cycle, (27) ICD-10 Condition: N949||Unspecified condition associated with female genital organs and menstrual cycle, (28) ICD-10 Condition: N950||Postmenopausal bleeding, (29) ICD-10 Condition: N96||Recurrent pregnancy loss, (30) ICD-10 Condition: N972||Female infertility of uterine origin, (31) ICD-10 Condition: N979||Female infertility, unspecified, (32) ICD-10 Condition: N979||Female infertility, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  omittance of ripening agent  omittance of tab misoprostol for cervical ripening prior to hysteroscopic procedures in perimenopausal patients 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  premenopausal
Indicated for diagnostic or Operative hysteroscopy
Willing and able to provide informed consent
 
 
ExclusionCriteria 
Details  Allergy to prostaglandins
Prior cervical surgery
Active pelvic infection
Pregnancy
Anatomical abnormalities (e.g., cervical stenosis, Müllerian anomalies)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the hysteroscope insertion ease in premenopausal woman undergoing hysteroscopy with or without cervical priming  at baseline (during procedure) 
 
Secondary Outcome  
Outcome  TimePoints 
To assess procedure time (starting from vaginoscopy to entering the uterine cavity)
To assess need for cervical dilatation in both groups
 		 at baseline (during procedure) 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   01/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Though Misoprostol has been routinely used prior to hysteroscopy, there are several studies that have concluded that cervical priming is not necessary. There are quite a few Indian studies that have evaluated ease of hysteroscopy after cervical priming with misoprostol. But there aren’t many that have evaluated unprimed cervix. With advancements in design and technology of hysteroscopy, the use of misoprostol can be omitted, as backed up by foreign authors. This study will be performed in Indian setup and help in providing evidence based hysteroscopy.

 
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